Cleared Traditional

K063236 - BETA-POWDER

K063236 is an FDA 510(k) clearance for BETA-POWDER, manufactured by Brainbase Corporation. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K063236 · Brainbase Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
114d
Days
Class 2
Risk

K063236 is an FDA 510(k) clearance for the BETA-POWDER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Brainbase Corporation (Shinagawa-Ku Tokyo, JP). The FDA issued a Cleared decision on February 16, 2007 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6080 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainbase Corporation devices

FDA 510(k) Submission Details - K063236

510(k) Number K063236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2006
Decision Date February 16, 2007
Days to Decision 114 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOJ Device Classification - Class 2, Special Controls

Product Code KOJ Airbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6080
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KOJ Airbrush

All 19
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K063236.
turbodent touch
K251425 · Mectron S.P.A. · May 2025
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
CLINPRO PROPHY POWDER
K021450 · 3M Espe AG Dental Products · Aug 2002
NEW PROPHY POWDER
K014188 · Dentsply Intl. · Mar 2002
KAVO CORUND HANDPIECE 2013
K002708 · Kavo America · Nov 2000
SIMPLEX AIRBRATOR (SAB-7)
K980672 · Irt Management Corp. · May 2000